E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
To investigate the effects of Mutaflor® Suspension on exercise induced gastrointestinal symptoms for 3 hours after a strenous exercise test on a treadmill |
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E.1.1.1 | Medical condition in easily understood language |
symptoms of the gut after strenous exercise |
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E.1.1.2 | Therapeutic area | Body processes [G] - Microbiological Phenomena [G06] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To investigate the effects of Mutaflor® Suspension on exercise induced pertubation of the gastrointestinal tract as shown by the biomarkers Zonulin and LPS for 3 hours after a strenous exercise test on a treadmill |
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E.2.2 | Secondary objectives of the trial |
To investigate the effects of Mutaflor® Suspension with regard to exercise induced
gastrointestinal integrity (1 laboratory marker)
LPS-Clearance (2 laboratory markers)
gastrointestinal damage (1 laboratory marker)
liver damage (2 laboratory markers)
systemic, inflammatory markers (white blood cell count and 7 further laboratory markers)
subjective gastrointestinal symptoms (questionnaire score)
for 3 hours after a strenous treadmill test |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Eligible subjects will be healthy, non-smoking males between 18 and 35 years, physically fit but not over-trained, with a BMI between 18.5 and 25 kg/m2, a maximum oxygen uptake (VO2max) of less than 53 ml/kg·min, with medically approved unrestricted sports participation as shown by diagnostic performance test conducted on bicycle no longer than 3 months prior to study entry. |
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E.4 | Principal exclusion criteria |
Subjects who meet one or more of the following criteria will disqualify for study entry: 1. Weekly training volume ≥ 3 hours 2. Use of dietary supplements (incl. high-dosed vitamins and minerals) 3. Chronic immune deficiency 4. Current infection 5. Heart and/or circulation disorders 6. Abnormal findings on exercise ECG 7. Musculoskeletal disorders 8. Any current clinical condition that requires systemic treatment or might have an impact on study objectives 9. Hypersensitivity to ingredients of Mutaflor Suspension 10. Illicit drug or alcohol abuse 11. Participation in another clinical trial within 4 weeks prior to study entry |
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E.5 End points |
E.5.1 | Primary end point(s) |
3-hour post-exercise levels of LPS
3-hour post-exercise levels of Zonulin
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.
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E.5.2 | Secondary end point(s) |
3-hour post-exercise levels of CLDN3 anti-LPS IgG/IgM PCSK9 I-FABP ALT AST white blood cell count Plasma Myeloperoxidase Malondialdehyd Calprotectin TNF-α IL-6 hsCRP IL-10
and additionally gi symptoms score |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Each laboratory parameter measured immediately at the end of the exercise test as well as three hours thereafter. Baseline values will be captured immediately before the exercise test.
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
prospektive, einarmige Studie |
single-arm, prospective study |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |